Product code EBA— Dental
FIBEROPTIC HEADLIGHT SYSTEM
- Classification name
- Light, Surgical Headlight
- Device class
- Class 1
- Regulation
- 21 CFR 872.4630
- Advisory panel
- Dental
- Total cleared
- 10
- First cleared
- Most recent
Market context for product code EBA
FDA has cleared devices under product code EBA between 1979 and 2007, filed by 9 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2007
- 1992
- 1989
- 1986
- 1984
- 1982
- 1981
- 1979
Top applicants under product code EBA
Recent clearances under product code EBA
- K070287 — PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500
- K923949 — SYLVAN DENTAL HEADLIGHT SYSTEM
- K893458 — FIBEROPTIC HEADLIGHT SYSTEM
- K854646 — VEGA DENTAL OPERATING LIGHT
- K842515 — SURGICAL HEADLIGHT
- K842358 — ISOLIGHT
- K822265 — FIBEROPTIC LIGHT SOURCE W/RELATED ITEMS
- K810117 — HALOGEN HEADLIGHT SYSTEM
- K790806 — PORCELIT
- K790807 — METALIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.